PROTAC SensOn Smirthwaite User Manual

Protac SensOn®
Directions for use Medical device
www.protac.dk

SensOn Smirthwaite

Protac SensOn ®
You have selected a quality Protac product. Protac guarantees that you have purchased an original, Danish designed product developed in consultation with experts.
Protac has developed, produced and sold sensory-stimulating aids to the healthcare sector in Denmark, the rest of Europe, Australia and New Zealand since 1994.
Protac products are developed on the basis of theories on sensory integration, and are supported by extensive research, documentation and case studies.
Protac focuses strongly on protection of the environment and safety during its production process. Protac plastic balls are certified STANDARD 100 by OEKO- TEX®nr. 2076-310 DTI.
The fabric are certified STANDARD 100 by OEKO-TEX®.
For more details, go to www.protac.dk
Labelling
The products are labeled in accordance with Regulation (EU) 2017/745 Class I medical devices.The label with details of manufacturer, raw materials and washing instructions is placed inside the pocket, to avoid irritating the user when wearing and to protect the label from wear.
Key to label symbols: please refer to Key to symbols

General precautions – Safety

Not to be used by people with poor balance without supervision
Not to be used by people who are unable to take care of themselves without supervision
Not to be used near an open fire
Not to be used to be slept with at night
Not to be used by children under the age of 3, as it contains small particles
Not to be used by driver or passenger during vehicle transport
Make sure to keep a check on the user’s reaction
Be aware not to stumble on the collar if it falls on the floor
Do not heat in a microwave or by means of other sources of heat.
Product purpose and areas of use
Sensory integration is the idea behind the development of all Protac products. The theory originated in the 1970s in the USA, and was developed by A. Jean Ayres, an occupational therapist and psychologist. The theory is based on how the brain processes sensory impressions, and how the various sensory stimuli can be influenced via applying weight and pressure to the tactile sense (the sense of touch) in the skin and the proprioceptive sense (the sense of movement) in muscles and joints. The pressure and movement of the balls act on these senses in particular.
Protac SensOn® is designed to be an aid for people with disabilities.
Children, young people, adults, and the elderly may use Protac SensOn®.

• Users with physical and motor unrest
• Users with physical and mental impairment following a brain injury
• Users with dementia
• Users with concentration problems
• For those with physical and motor unrest, Protac SensOn® can be used for improved concentration and learning abilities as the weight and pressure of the beads provide additional sensory stimulation and increased comfort
• People with a psychiatric illness often suffer physical and motor unrest. Protac SensOn® can be used to calm and comfort the user. The weight and pressure of the balls improve comfort and well-being.

Protac SensOn® can be used in institutions, homes, daycare centres, hospitals, waiting rooms, and private areas. Schoolchildren can benefit from Protac SensOn® during teaching in order to help them maintain focus on a task. In institutions, users can wear Protac SensOn® while eating. In private homes, users can wear Protac SensOn® while eating or when reading in order to improve their concentration.
Using the product

Product service life
The product has an expected service life of 2 years.
This is based on correct use, cleaning, washing, service and maintenance.
Products used beyond the aforementioned service life should be assessed for further use.
Responsibility for using the product beyond the stated service life rests with the user.
Cleaning
Protac SensOn® is washable. The need for washing depends on its use. When washing and cleaning, follow the instructions below.

• Protac SensOn® can be washed in a washing machine with a capacity of at least 6 kg using a detergent without bleach and perfume. Please refer to the washing instructions in the Protac SensOn®.
• Use the washing bag supplied.

To remove spots using a spot remover, always try first on an area which is not visible to test for damage or discolouring. Protac does not recommend the use of spot remover.

Maintenance

Air the product regularly.
Transport and storage
Protac SensOn® is supplied ready for use. Protac SensOn® is packed in a carry bag for easy transport to protect it against dirt and moisture.
Protac SensOn® is best stored flat and covered to protect it against dirt and moisture.
Disposal
Upon disposal, Protac SensOn® can be sorted into plastic and fabric.
The plastic balls can be disposed of as hard plastic.
All parts of the chair can be disposed of as combustible waste.
Waste must be disposed of in accordance with applicable rules.
Guarantee
2 year guarantee against manufacturing defects.
The guarantee will be invalid in the event of the following:

• Over-use
• Misuse
• Non-maintenance or incorrect maintenance

Traceability: The month and year of manufacturer and batch number are marked on the CE- andwashing instructions label.

Key to symbols

Example only. Always follow the recommended care instructions on the label found inside the product

| Washing bowl: Maximum washing temperature (see care label)
---|---
| Triangle: Do not bleach
| Square with a circle: tumble drying possible (see care label)
| Iron: Do not iron
| Circle: Do not dry clean
| Warning: See under Safety
| User information
| For indoor use
| CE marked according to (EU) 2017/745 Class I medical devices
| Manufacturer
| Batch number

Technical specifications

Standards: Comply with general requirements for aids acc. to the following harmonized standards:
Clinical evaluation: EN 12182:2012
Risk analysis: DS/EN ISO 14971:2019/A11:2021
Quality management systems: EN ISO 13485:2016/A11:2021
Service information
No other balls can be used in a Protac SensOn® than those used by the manufacturer.
Guide
– to daily inspection of Protac SensOn® before use

Protac A/S
Niels Bohrs Vej 31 D, Stilling
DK-8660 Skanderborg
Tel.: 86 19 41 03
e-mail:protac@protac.dk
Distributor list: Please refer to:www.protac.dk/kontakt
Medical device
TD 5.7-1 – Protac SensOn® – Juni 2022. Version 7

References

• Protac.dk | Beroligende og sansestimulerende hjælpemidler med kugler

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